VITA-D: Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT00752401

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Vitamin D Deficiency Renal Osteodystrophy	Drug: Cholecalciferol Drug: Placebo	Phase 3

Detailed Description

Apart from its classical actions in calcium homeostasis, vitamin D acts as a potent immunomodulatory agent. As such, vitamin D is thought to have beneficial effects in the transplant setting, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin D deficient.

Therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in vitamin D deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (CRP levels) of posttransplant infections within the first year after kidney transplantation.

Moreover, the impact of Vitamin D3 on renal osteodystrophy will be analyzed by means of bone mineral density. DXA measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant.

Kidney transplant recipients found to have vitamin D deficiency (defined as 25-hydroxyvitamin D < 50 nmol/l) will be included and will be randomized to receive either oral Vitamin D3 therapy or placebo. Vitamin D3 will be administered at a daily dose of 6800IU over a time period of one year.

All in all, 200 subjects will be included in the VITA-D study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year	Drug: Cholecalciferol 6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day. Other Names: Vitamin D3 Oleovit® D3
Placebo Comparator: 2 Oral placebo solution daily for one year	Drug: Placebo An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.

Arm

Intervention/Treatment

Active Comparator: 1

6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year

Drug: Cholecalciferol

6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day.

Other Names:

Vitamin D3

Oleovit® D3

Placebo Comparator: 2

Oral placebo solution daily for one year

Drug: Placebo

An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.

Outcome Measures

Primary Outcome Measures

The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate [one year after kidney transplantation]
Number of acute rejection episodes [one year after kidney transplantation]
Number of infections [one year after kidney transplantation]
CRP levels [one year after kidney transplantation]
Courses of calcium levels [within the first year after kidney transplantation]

Secondary Outcome Measures

The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2) [within the first year after kidney transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 18
deceased donor kidney transplant recipients
only kidney transplant recipients
vitamin D deficiency defined as 25 (OH)D < 50nmol/l

Exclusion Criteria:

re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
re-transplantation for the third or further time
significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
severe liver disease: cirrhosis
HIV positive